Cleared Special

U2 Total Knee System, XPE Tibial Insert, PS PLUS

K210961 · United Orthopedic Corporation · Orthopedic

Apr 2021

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K210961 is an FDA 510(k) clearance for the U2 Total Knee System, XPE Tibial Insert, PS PLUS, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on April 21, 2021, 21 days after receiving the submission on March 31, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K210961 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2021
Decision Date	April 21, 2021
Days to Decision	21 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560